Standard Operating Procedure for Weight Variation Control in Extended Release Tablets
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/159/2025 |
| Supersedes | SOP/TAB/159/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
To establish a standardized procedure for controlling and monitoring weight variation in extended-release tablets, ensuring that each tablet meets the required weight specifications and remains consistent during production.
2. Scope
This SOP applies to the production of extended-release tablets, focusing on monitoring and controlling weight variation to ensure uniformity and compliance with product specifications during tablet manufacturing.
3. Responsibilities
- Quality Control (QC): Responsible for performing weight variation testing, documenting results, and ensuring that tablets meet the specified weight limits.
- Production Operator: Responsible for maintaining consistent tablet weight during the compression process and notifying QC when weight variation testing is required.
- Quality Assurance (QA): Ensures that weight variation control procedures are followed according to this SOP and reviews the documentation for compliance.
4. Accountability
The QC Manager is accountable for ensuring that weight variation testing is conducted regularly and that any deviation from the weight specifications is properly addressed. The QA Manager ensures that the procedure is followed according to this SOP and approves corrective actions as necessary.
5. Procedure
5.1 Preparation for Weight Variation Testing
- Ensure the tablet compression machine is set correctly for extended-release tablet production, maintaining the appropriate compression pressure.
- Verify that the batch of materials is ready for compression, including the appropriate excipients and API.
- Ensure that the necessary equipment for weight variation testing, such as analytical balances and sampling containers, is available and calibrated.
5.2 Sampling of Tablets
- Sample at least 20 tablets from each batch or according to the specified sample size in the batch record.
- Ensure that tablets are sampled randomly from the tablet press to provide a representative sample of the batch.
- Label the samples with the batch information and ensure they are properly documented.
5.3 Weight Variation Testing
- Weigh each tablet individually on a calibrated analytical balance to the nearest milligram.
- Record the weight of each tablet and calculate the average weight of the sample.
- Check the weight variation against the specified limits outlined in the product’s quality specifications. The acceptable variation is typically ±5% of the average weight for extended-release tablets.
- If the variation exceeds the permissible limits, the batch will be considered out of specification (OOS) and corrective actions must be taken.
5.4 Documentation of Results
- Document the individual weights of the sampled tablets, the average weight, and the results of the weight variation test in the batch record (Annexure-2).
- Note any deviations from the acceptable weight variation limits and indicate corrective actions taken in the deviation report (Annexure-1).
5.5 Corrective Actions for Weight Variation Issues
- If weight variation exceeds the acceptable limits, investigate potential causes such as incorrect formulation, issues with tablet compression, or worn-out tooling.
- Adjust the tablet compression settings, such as the die and punch alignment, tablet press speed, or compression pressure.
- If the issue is related to formulation, review the excipient composition and ensure uniform distribution of the active ingredient.
- After making adjustments, re-sample the batch and perform weight variation testing again to confirm that the issue has been resolved.
5.6 Acceptance Criteria
- The batch is considered acceptable if the weight variation for at least 95% of the sampled tablets falls within the predefined limits (typically ±5%).
- If more than 2 tablets in the sample fail the weight variation test, the batch should be rejected, and a deviation report should be created.
5.7 Post-Testing Actions
- If the batch passes the weight variation test, proceed with the next step in the tablet manufacturing process, such as coating or packaging.
- If the batch fails, take corrective actions as outlined in the deviation report and rework or reject the batch as necessary.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- OOS: Out of Specification
7. Documents
- Batch Record (Annexure-2)
- Deviation Report (Annexure-1)
8. References
- USP <701> – Uniformity of Dosage Units
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Guidelines for Tablet Manufacturing
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 15/12/2025 | Batch 001 | Weight variation exceeded acceptable limits | Adjusted compression pressure and recalibrated equipment | John Doe |
Annexure-2: Batch Record
| Sample Number | Weight | Variation (%) | Tested By |
|---|---|---|---|
| Sample 1 | 700 mg | ±3% | Jane Smith |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/02/2025 | 2.0 | Updated weight variation testing procedure | Improved test consistency and accuracy | QA Head |